SIGMA 96-2366Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295242550), received between Jan 7, 2019 and Sep 24, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Naturally Worn” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient had chronically infected knee. Surgeon did washout and poly exchange.DOI: Unknown.DOR: (b)(6) 2026.Affected side: Left knee.

  Patient problems: Unspecified Infection

  MAUDE report 50889254 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient needed a thicker poly from 22.5 to 30.DOI: Unknown.DOR: (b)(6) 2026.Affected Side: Right Knee.

  Patient problems: Insufficient Information

  MAUDE report 50060749 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25216616 ↗
• InjuryDec 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A REVISION KNEE DONE ON (B)(6) 2022, USING THE SIGMA TC3 SYSTEM. POST OP PATIENT DID GREAT. SINCE THE SURGERY, THE PATIENT HAS HAD SEVERAL FALLS AND AS A RESULT THE OPERATIVE KNEE HYPEREXTENDS A FEW DEGREES. SURGEON BROUGHT PATIENT TO THE OR TO INCREASE THE POLY THICKNESS TO STOP THE KNEE FROM HYPEREXTENDING. DURING THE PROCEDURE, SURGEON EXAMINED THE FEMORAL AND TIBIAL COMPONENTS AND DETERMINED THAT BOTH WERE WELL FIXED. SURGEON TRIALED A 25MM AND 30MM POLY INSERT AND DETERMINED THAT THE 30MM GAVE PATIENT THE DESIRED MOTION. A 30 MM TC3 POLY WAS PLACED AND SURGEON CLOSED THE KNEE. SURGEON NOTED THAT THE PATIENT'S KNEE WAS STABLE AND HAD GREAT RANGE OF MOTION. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Joint Laxity; Loss of Range of Motion

  MAUDE report 21020916 ↗
• InjuryMay 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INFECTION IN THE KNEE NECESSITATED A POLY SWAP WITH NO OTHER COMPLICATIONS. NO ADDITIONAL DETAILS WERE AVAILABLE. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19392218 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON PERFORMED A DEBRIDEMENT AND INSERT EXCHANGE. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2010, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 19019909 ↗
• InjuryMar 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A POLY SWAP WAS PERFORMED ON A PATIENT. DOI: (B)(6) 2015. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18885158 ↗
• InjuryFeb 5, 2024Naturally Worn; Naturally Worn

  SUBJECT ID: (B)(6); STUDY NO: DOTS. CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO POLY WEAR. DATE OF IMPLANT: (B)(6) 2008, DATE OF REVISION: (B)(6) 2024, (LEFT KNEE). TREATMENT: INSERT AND PATELLA WERE REVISED.

  Patient problems: Insufficient Information

  MAUDE report 18640497 ↗
• InjuryMay 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS SEEN IN DOCTOR'S OFFICE LAST WEEK FOR A SUDDEN ONSET OF SWELLING IN LEFT KNEE. PATIENT HAD A KNEE REVISION IN THAT KNEE IN JULY OF LAST YEAR. DOCTOR DID WORK UP FOR INFECTION. PATIENT'S LABS WERE ELEVATED CONSISTENT WITH INFECTION OF THE JOINT. AN I&D WITH POLY EXCHANGED WAS SCHEDULED. DURING SURGERY THE POLY WAS REMOVED, IT WAS NOTED THAT FEMORAL AND TIBIAL COMPONENTS WERE BOTH WELL FIXED. AN I & D WAS PERFORMED AND A NEW POLY WAS IMPLANTED. THE JOINT IS STABLE WITH GOOD RANGE OF MOTION. THERE IS NO FURTHER INFORMATION AVAILABLE. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 16867663 ↗
• InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT FEMORAL REVISION ONLY AND CONVERSION TO A HINGED FEMORAL PROSTHESIS DUE TO MEDIAL COLLATERAL INSTABILITY. NO FURTHER INFORMATION AVAILABLE. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15996067 ↗
• InjuryApr 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PATELLA PAIN AND LOOSENESS. DURING SURGERY THE SURGEON FOUND PATELLA FRACTURED AND NOT TRACKING PROPERLY. PATELLA WAS TOO THIN FOR RESURFACING. THE SURGEON MADE A FEW RELEASES, RONGEURED PATELLA INTO BEST POSSIBLE SHAPE AND REPLACED POLY. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2020, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11732665 ↗
• InjuryDec 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN DOR: (B)(6) 2020 RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 10950781 ↗
• InjuryDec 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A POLY EXCHANGE DUE LAXITY. DOI: (B)(6) 2018; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: Joint Disorder

  MAUDE report 9418626 ↗
• InjuryJan 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 8222375 ↗